PharMEDium Recalls Potassium Phosphate Injection Due to Sterility Concerns
PharMEDium Services is recalling specific lots of Potassium Phosphate in 5% Dextrose Injection due to a media fill failure that compromised sterility assurance.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury or infection.
Plain-English summary
PharMEDium Services, LLC is recalling specific lots of Potassium Phosphate in 5% Dextrose Injection, 9 mMol in 50 mL in 50 mL Intravia Bag. The recall was initiated because of a lack of assurance of sterility resulting from a media fill failure at the manufacturer.
The affected product is identified by NDC 61553-310-41. The specific lots subject to the recall are 171160002S (expiration date 7/26/2017) and 171560007S (expiration date 9/4/2017). The product was distributed nationwide.
Healthcare providers and patients should discontinue use of the affected lots and contact PharMEDium Services for further instructions or returns.
The recalled product
- Product
- Potassium PHOSphate in 5% Dextrose Injection, 9 mMol in 50 mL in 50 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5310 NDC# 61553-310-41
- Manufacturer
- PharMedium Services, Llc
- Category
- Drug — Injectable
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lots: 171160002S Exp. 7/26/2017
- 171560007S Exp. 9/4/2017
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 recalled by PharMedium Services, Llc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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